Events

Alerte De Sécurité sur Monitor/ Defibrillator DEFIGARD Touch7

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Schiller Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-01-30
  • Date de publication de l'événement
    2017-01-30
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180130.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: schiller medical, monitor/ defibrillator defigard touch7 the health sciences authority (hsa), singapore posted a medical device safety alert concerning monitor/ defibrillator defigard touch7 [all devices with software version up to “soft 5” are affected]. the defigard touch7 can be configured in 3 different start modes (monitoring, aed or manual defibrillator). the field safety notice concerns devices configured in start mode “manual defibrillator’. if the user starts the device in this configuration, and switches directly from the manual defibrillation to the synchronized defibrillation mode, without ecg patient cable being plugged, then the device will be unable to trigger the synchronized defibrillation shock. this can be seen on the screen of the device, no trigger pulses are available. if the patient cable is connected, according to the user manual, this failure does not occur. according to the manufacturer, it may be unable to perform synchronized defibrillation therapy. the manual defibrillation mode at start is a specific medical emergency service setting. it is used when rescuer wants to mainly use the device as manual defibrillator. the synchronized defibrillation is not an emergency procedure, and it is recommended to perform it with ecg patient cable. while waiting for the update of the defigard touch 7, affected users are advised to continue to use it without restriction. if user startup configuration with manual defibrillation mode, user has to select another startup mode, until the update to software “soft 6”, or use a patient cable for the synchronized defibrillation therapy, as described in the user manual. for details, please visit the following hsa website: http://www.Hsa.Gov.Sg/content/dam/hsa/hprg/medical_devices/updates_and_safety_reporting/field_safety_corrective_action/fsn/2017/november/hsa%206004101-056-17-06_36%20fsn_redacted.Pdf if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 january 2017.

Device

Monitor/ Defibrillator DEFIGARD Touch7
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Schiller Medical, Monitor/ Defibrillator DEFIGARD Touch7
  • Manufacturer
    Schiller Medical

Manufacturer

Schiller Medical